NCT00628277

Brief Summary

We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight loss counseling would lead to a greater loss of fat mass and a greater improvement in cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation exercise plus counseling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at below P25 for phase_3 obesity

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_3 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
Last Updated

March 5, 2008

Status Verified

February 1, 2008

Enrollment Period

4.8 years

First QC Date

February 26, 2008

Last Update Submit

February 26, 2008

Conditions

Obesity

Keywords

Obesitycoronary heart diseasecoronary risk factorsweight lossexercise

Outcome Measures

Primary Outcomes (1)

  • Fat Mass

    4 months, 12 months

Secondary Outcomes (2)

  • Intrabdominal (visceral) fat

    4 months

  • Insulin stimulated glucose disposal

    4 months

Study Arms (2)

1

EXPERIMENTAL

Arm 1: high caloric expenditure exercise plus dietary counseling

Behavioral: high caloric expenditure exercise

2

ACTIVE COMPARATOR

Arm 2: low caloric expenditure exercise plus dietary counseling

Behavioral: low caloric expenditure exercise plus dietary counseling

Interventions

high caloric expenditure exerciseBEHAVIORAL

high caloric expenditure exercise plus dietary counseling

1
low caloric expenditure exercise plus dietary counselingBEHAVIORAL

low caloric expenditure exercise plus dietary counseling

2

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary heart disease
  • BMI \> 27
  • Peak Vo2 \> 14.4 ml/kg/min

You may not qualify if:

  • Presence of diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont College of Medicine

Burlington, Vermont, 05401, United States

Location

Related Publications (2)

  • Ades PA, Savage PD, Lischke S, Toth MJ, Harvey-Berino J, Bunn JY, Ludlow M, Schneider DJ. The effect of weight loss and exercise training on flow-mediated dilatation in coronary heart disease: a randomized trial. Chest. 2011 Dec;140(6):1420-1427. doi: 10.1378/chest.10-3289. Epub 2011 Jul 21.

    PMID: 21778256DERIVED

  • Ades PA, Savage PD, Toth MJ, Harvey-Berino J, Schneider DJ, Bunn JY, Audelin MC, Ludlow M. High-calorie-expenditure exercise: a new approach to cardiac rehabilitation for overweight coronary patients. Circulation. 2009 May 26;119(20):2671-8. doi: 10.1161/CIRCULATIONAHA.108.834184. Epub 2009 May 11.

    PMID: 19433757DERIVED

MeSH Terms

Conditions

ObesityCoronary DiseaseWeight LossMotor Activity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesBody Weight ChangesBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Philip A Ades, MD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 5, 2008

Study Start

October 1, 2002

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

March 5, 2008

Record last verified: 2008-02

Locations

US(1)